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NCT Number: NCT03112616

The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients

One of the causes of disability in patients suffering from a stroke is postural imbalance. Sensory stimulation improves the postural symmetry of the subject transitorily and they are thought to have an effect on the spatial frame of reference through a sensory recalibration. Studies have shown that sensory stimulation by vibration of neck muscles have an immediate effect on static balance and when walking. The objective of this preliminary study is to test the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in standing position and on spatial frame reference in chronic patients.

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Key information

Conditions

Hemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes - Pontchaillou Hospital

Rennes, Brittany Region, 35000, France

About this study

The hypothesis of this study is that the proprioceptive repeated stimulation by vibration of neck muscles in the long term improved postural asymmetry in connection with the egocentric representation of body disorders.

The effect of vibration simultaneously on improving postural asymmetry and on improving markers of the perception of the body in space (LBA, SSA, Subjective Visual Vertical (SVV), Rod and frame) will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (age ≥ 18 years) under 80 years,
  • Right or left unilateral supratentorial ischemic or hemorrhagic lesion
  • The first symptomatic episode
  • Stroke
  • older than 12 months
  • with or without hemianopsia
  • with or without visuospatial hemineglect
  • Standing balance ≥ 30 sec unaided
  • Percentage of weight bearing asymmetry on the hemiplegic lower limb (on a force platform)
  • Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)

Exclusion criteria

  • Orthopaedic, rheumatologic, neurologic, vestibular or visual disorders affecting the distribution of the centre of pressure while standing on the force platform
  • Visual disorder that does not allow assessment of the spatial frame of reference test
  • Difficulty with understanding protocol procedures

Treatment and study plan

Vibration sessions

Other

The patients will undergo a program of 10 sessions of vibrations of the neck muscle, each of 10 minutes, during a period of 15 days at the rate of one session per day.

Primary outcomes

  1. Changes from baseline Weight Bearing Asymmetry at Day 15

    Time frame: Before and after the intervention program (Day 15)

    The primary evaluation criteria is the percentage of the Weight Bearing Asymmetry on the hemiparetic lower limb (WBA) calculated as the mean of 4 trys, each based on a 30 seconds duration with the two eyes open (OP) and then again with the two eyes closed. This evaluation is realized on a force platform.

Secondary outcomes

  1. Haptic and visual Subjective Straight Ahead (SSA) test

    Time frame: 7 days and 15 days after the start of the intervention

    The effect on spatial reference frame evaluated by haptic and visual Subjective Straight Ahead (SSA) test

  2. Subjective Visual Vertical (SVV) test

    Time frame: 7 days and 15 days after the start of the intervention

    The effect on spatial reference frame is evaluated by Subjective Visual Vertical (SVV) test

  3. Evaluation of Longitudinal Body Axis (LBA)

    Time frame: 7 days and 15 days after the start of the intervention

    The effect on spatial reference frame is evaluated on Longitudinal Body Axis (LBA)

  4. Rod and Frame Test

    Time frame: 7 days and 15 days after the start of the intervention

    The effect on spatial reference frame is evaluated by the Rod and Frame Test

  5. Change from baseline of patients' motor skills

    Time frame: 1 month after the end of the program

    Assessment of motor skills with simple motor tasks

  6. Change from baseline of patients' sensitivity

    Time frame: 1 month after the end of the program

    Assessment of superficial tact on the hemiplegic lower limb compared to the safe limb

  7. Change from baseline of patients' spasticity

    Time frame: 1 month after the end of the program

    Assessment of spasticity with Ashworth Modified scale

  8. Change from baseline of patients' functional capacity

    Time frame: 1 month after the end of the program

    Functional capacity is a composite index made of sensitivity test, motor scale and spasticity scale

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position and on Spatial Frame Reference in Chronic Stroke Patients

Acronym: VIBR-HEMI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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